Data / Medical devices / Stirrup, External Brace Component
Stirrup, External Brace Component (ITC): 29 FDA-registered makers in 11 countries
29 establishments in 11 countries are registered with the FDA to make Stirrup, External Brace Component (product code ITC, Class 1, 21 CFR 890.3410). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ITC
- Device class
- 1
- Regulation
- 890.3410
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| China | 6 |
| Mexico | 2 |
| Netherlands | 1 |
| Vietnam | 1 |
| India | 1 |
| Belgium | 1 |
| Taiwan | 1 |
| Germany | 1 |
| Thailand | 1 |
| United Kingdom | 1 |
Makers of Stirrup, External Brace Component
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abletech Orthopedics Corporation | New Taipei City Taiwan, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Basko Healthcare B.V. | ZAANDAM Noord-Holland, Netherlands | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becker Orthopedic Appliance Co. | Troy, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Border Opportunity Saver Systems, Inc. | Del Rio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan SAVA Sporting Products Co.,Ltd | Dongguan City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Orthopaedics, Inc. | South El Monte, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer, LLC | Chattanooga, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Hexin Technology Weaving Co., LTD | Huizhou City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GuoLong (Shenzhen) High Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hameco Hy Co., Ltd | Hung Yen Province, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & D Tech Inc | Nesconset, NY, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquiladora De Coahuila S De RL De CV | CUIDAD ACUNA Coahuila, Mexico | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Northeast Medical Systems And Design, LLC | Cherry Hill, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orfit Industries NV | WIJNEGEM Antwerpen, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Overland Int'l Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | DUDERSTADT Lower Saxony, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Restorative Care Of America, Inc. | Saint Petersburg, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Secure Manufacturing (thailand) Co., Ltd. | Bangkok Krung Thep Maha Nakhon, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Secured Ortho Manufacturing Of America, LLC | Deer Park, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Span Link International LLC | Deer Park, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ST&G Usa Corporation / Choi | Brea, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trulife, Ltd. | S. Yorkshire Sheffield, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangpu Ortholife Rehabilitation Co., Ltd | Zhangzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangzhou Recaring Medical Instrument Co., Ltd | Zhangzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.